Global In Vitro Diagnostics (IVD) Quality Control Market Growth, Share, Size, Trends and Forecast (2025 - 2031)

• In November 2023, Merck KGaA launched ChemisTwin to analyze the sample’s purity, identification, and degradation of compounds through calibrated algorithm-based digital references.

• In June 2023, Randox Laboratories Ltd acquired Cellix Limited to expand its market footprint in personalized medicine and improve preventative healthcare.

• In May 2023, ZeptoMetrix launched PROtrol, a new line of quality control products for antigen-based diagnostics methods, such as the lateral flow immunoassay for infectious diseases.

• In March 2023, SeraCare Life Sciences Inc. released Seraseq BRCA1/2 large genomic rearrangements reference materials to meet clinical laboratory testing needs for somatic and germline levels.

• In January 2023, QIAGEN launched the EZ2 Connect MDx IVD platform for automated sampling in diagnostic laboratories.

The Global In Vitro Diagnostics (IVD) Quality Control Market is segmented by Application, Manufacturer Type, Quality Control Type, End Use, and Geography, providing a detailed analysis of the factors shaping the quality control landscape in IVD diagnostics. This segmentation reflects the diverse needs for ensuring accuracy, reliability, and regulatory compliance in IVD products across various industries and regions.

By Application, the market includes critical areas such as Clinical Chemistry, Microbiology, Hematology, Immunology, and Molecular Diagnostics. Clinical chemistry and microbiology dominate this segment, driven by the need for high accuracy and precision in diagnostic testing, especially in detecting infectious diseases and metabolic disorders. Immunology and molecular diagnostics are growing segments, benefiting from advances in antibody testing and genomic analysis, requiring stringent quality control to ensure the reliability of results.

The Manufacturer Type segment is divided into OEM (Original Equipment Manufacturer) and Third-Party Manufacturers. OEMs typically offer integrated quality control solutions that are customized to their diagnostic platforms, ensuring compliance with regulatory standards. Third-party manufacturers, on the other hand, provide independent quality control materials that can be used across various IVD platforms, offering flexibility and often lower costs. Quality Control Types include External Control, Internal Control, and Proficiency Testing. External control materials are widely used to ensure test accuracy during operations, while internal controls monitor testing procedures in real-time. End Users of IVD quality control materials include Hospitals, Diagnostic Laboratories, and Clinical Research Organizations, all of which rely on consistent quality assurance for accurate diagnostics. Geographically, regions like North America, Europe, Asia-Pacific, and Latin America exhibit varying growth rates, influenced by healthcare infrastructure, regulatory environments, and market demand for high-quality diagnostic solutions. Together, these segments highlight the critical role of quality control in maintaining the accuracy and reliability of in vitro diagnostic tests across multiple applications.

Global In Vitro Diagnostics (IVD) Quality Control Segment Analysis

In this report, the Global In Vitro Diagnostics (IVD) Quality Control Market has been segmented by Application, Manufacturer Type, Quality Control Type, End Use, and Geography.

Global In Vitro Diagnostics (IVD) Quality Control Market, Segmentation by Application

The Global In Vitro Diagnostics (IVD) Quality Control Market has been segmented by Application into Immunochemistry, Clinical Chemistry, Hematology, Coagulation, Molecular Diagnostics, Microbiology, and Others.

Immunochemistry represents a critical application segment within the IVD Quality Control Market, encompassing diagnostic tests for the detection and quantification of proteins, antibodies, hormones, and other biomolecules in biological specimens. Immunoassays such as enzyme-linked immunosorbent assays (ELISA), chemiluminescent immunoassays (CLIA), and fluorescence immunoassays (FIA) are widely used in clinical laboratories and healthcare settings for diagnosing infectious diseases, autoimmune disorders, endocrine disorders, and cancer. Quality control materials and solutions play a crucial role in verifying the performance of immunochemistry assays, ensuring the accuracy, precision, and reliability of test results, and maintaining compliance with regulatory standards.

Clinical chemistry diagnostics constitute another significant application segment within the IVD Quality Control Market, encompassing tests for measuring biochemical analytes such as glucose, cholesterol, electrolytes, enzymes, and metabolites in blood, serum, plasma, and urine samples. Clinical chemistry analyzers utilize various analytical techniques, including spectrophotometry, chromatography, and electrophoresis, to quantify analytes and assess physiological functions related to metabolism, organ function, and disease states. Quality control materials and solutions are essential for monitoring the accuracy and precision of clinical chemistry assays, detecting systematic errors and instrument malfunctions, and ensuring the reliability of test results for patient care and clinical decision-making.

Hematology diagnostics represent a critical aspect of the IVD Quality Control Market, focusing on tests for assessing blood cell counts, morphology, and hemostasis parameters. Hematology analyzers and coagulation instruments are utilized in clinical laboratories and healthcare facilities to perform complete blood counts (CBC), differential leukocyte counts, platelet counts, and coagulation assays such as prothrombin time (PT), activated partial thromboplastin time (aPTT), and fibrinogen assays. Quality control materials and solutions enable laboratories to monitor the accuracy and precision of hematology and coagulation assays, detect instrument deviations and reagent lot variations, and ensure the reliability of test results for diagnosing and managing hematological disorders and coagulopathies.

Global In Vitro Diagnostics (IVD) Quality Control Market, Segmentation by Manufacturer Type

The Global In Vitro Diagnostics (IVD) Quality Control Market has been segmented by Manufacturer Type into Third-Party Control Manufacturers and Original Equipment Manufacturers.

The Global In Vitro Diagnostics (IVD) Quality Control Market is segmented by Manufacturer Type into Third-Party Control Manufacturers and Original Equipment Manufacturers (OEMs). This segmentation highlights the different approaches to providing quality control solutions for IVD products, each with unique advantages and market dynamics.

Original Equipment Manufacturers (OEMs) typically offer integrated quality control materials that are specifically designed to work with their own diagnostic systems. These quality control solutions are tailored to ensure optimal performance and compliance with regulatory standards for the specific platform they are associated with. OEMs benefit from providing comprehensive packages that combine testing reagents, instruments, and control materials, ensuring a seamless user experience. This type of quality control is highly preferred by healthcare providers who use equipment from specific manufacturers, as it guarantees compatibility and reliability within the system.

On the other hand, Third-Party Control Manufacturers offer independent quality control materials that can be used across a variety of IVD platforms, regardless of the manufacturer. These controls provide flexibility and often serve as a cost-effective alternative to OEM-specific solutions. Third-party manufacturers are vital in promoting competition within the market, offering a broad range of quality control products that can be used in diverse diagnostic settings. Many diagnostic laboratories and healthcare facilities favor third-party controls due to their versatility and the ability to standardize quality checks across multiple instruments from different manufacturers. Together, both segments contribute to a robust quality control market, catering to the diverse needs of healthcare providers and diagnostic laboratories.

Global In Vitro Diagnostics (IVD) Quality Control Market, Segmentation by Quality Control Type

The Global In Vitro Diagnostics (IVD) Quality Control Market has been segmented by Quality Control Type into Quality Control, Quality Assurance Services, and Data Management Solutions.

Quality control (QC) materials constitute a significant segment within the IVD Quality Control Market, encompassing reference materials, calibration standards, and proficiency testing samples used to monitor the accuracy and precision of diagnostic assays and instruments. Assayed QC materials are characterized and assigned target values for specific analytes, enabling laboratories to verify the performance of their testing methods and detect systematic errors or deviations. Unassayed QC materials serve as reference materials for verifying instrument calibration and assessing measurement accuracy, ensuring consistency and traceability in diagnostic testing. Proficiency testing samples are distributed by external quality assessment organizations to laboratories for interlaboratory comparison and performance evaluation, enabling laboratories to identify areas for improvement and maintain analytical proficiency.

Quality assurance (QA) services represent another essential segment of the IVD Quality Control Market, encompassing consulting, training, and accreditation support services aimed at enhancing laboratory quality management systems and regulatory compliance. QA services providers offer expertise in quality management principles, regulatory requirements, and best practices for laboratory operations, assisting laboratories in developing and implementing quality policies, procedures, and documentation. These services include gap analysis, internal audits, and proficiency testing program participation to assess and improve laboratory performance and ensure compliance with accreditation standards such as ISO 15189 and CLIA. Additionally, QA services providers offer training programs and workshops on QC practices, instrument maintenance, and assay validation to enhance laboratory staff competency and proficiency.

Data management solutions constitute a growing segment within the IVD Quality Control Market, encompassing software platforms, informatics solutions, and cloud-based applications designed to streamline QC data management, analysis, and reporting. Data management solutions enable laboratories to capture, store, and analyze QC data generated from diagnostic instruments and assays, facilitating real-time monitoring of analytical performance and trend analysis. These solutions offer features such as electronic QC records, dashboards, and customizable reports to visualize QC metrics, identify outliers, and track instrument performance over time. Integration with laboratory information systems (LIS) and middleware platforms enables seamless data exchange and interoperability, enhancing workflow efficiency and regulatory compliance. Moreover, cloud-based data management solutions offer scalability, accessibility, and data security features, enabling remote monitoring and collaboration among laboratory stakeholders.

Global In Vitro Diagnostics (IVD) Quality Control Market, Segmentation by End Use

The Global In Vitro Diagnostics (IVD) Quality Control Market has been segmented by End Use into Home Care, Laboratory, Hospitals, and Others.

Home care represents an emerging segment within the IVD Quality Control Market, reflecting the growing trend towards decentralized testing and patient-centered care models. Home care settings encompass diagnostic testing performed outside traditional healthcare facilities, such as in patients' homes, community centers, and long-term care facilities. Point-of-care testing (POCT) devices and self-testing kits enable patients to perform diagnostic tests conveniently and monitor their health conditions from the comfort of their homes. Quality control materials and solutions tailored for home use provide patients with assurance regarding the accuracy and reliability of test results, ensuring confidence in self-management and treatment decisions. Additionally, remote monitoring and telehealth platforms facilitate data sharing and communication between patients and healthcare providers, enhancing care coordination and continuity across home care settings.

Laboratories represent a primary end-use segment within the IVD Quality Control Market, encompassing clinical laboratories, reference laboratories, and diagnostic manufacturers involved in diagnostic testing and research activities. Clinical laboratories perform diagnostic testing for patient care, disease diagnosis, and monitoring across various medical specialties, relying on QC materials and solutions to ensure the accuracy, precision, and reliability of test results. Reference laboratories provide specialized testing services, proficiency testing programs, and external quality assessment schemes to support laboratory quality management and accreditation. Diagnostic manufacturers develop and supply QC materials, instruments, and software solutions to the healthcare industry, driving innovation and quality improvement in diagnostic testing. Laboratory accreditation bodies such as the Clinical Laboratory Improvement Amendments (CLIA) and the International Organization for Standardization (ISO) set standards and guidelines for laboratory quality management systems and QC practices, ensuring the integrity of diagnostic testing and patient care.

Hospitals represent another key end-use segment within the IVD Quality Control Market, encompassing large tertiary care centers, academic medical centers, and community hospitals. Hospitals serve as central hubs for healthcare delivery, offering a wide range of medical services, including diagnostic testing, treatment, and specialized care across various medical specialties. QC materials and solutions are essential components of hospital laboratory operations, enabling laboratories to monitor the accuracy and precision of diagnostic assays, ensure compliance with regulatory standards, and maintain patient safety and quality of care. Automated analyzers, immunoassay systems, and POCT devices are commonly used in hospital laboratories to perform routine and specialized diagnostic tests, supporting timely intervention and optimal patient outcomes.

Global In Vitro Diagnostics (IVD) Quality Control Market, Segmentation by Geography

In this report, the Global In Vitro Diagnostics (IVD) Quality Control Market has been segmented by Geography into five regions; North America, Europe, Asia Pacific, Middle East and Africa and Latin America.

Global In Vitro Diagnostics (IVD) Quality Control Market Share (%), by Geographical Region, 2024

The Global In Vitro Diagnostics (IVD) Quality Control Market is influenced by geographical factors, with different regions contributing varying shares to the overall market landscape.

North America holds a significant share of the Global IVD Quality Control Market, driven by advanced healthcare infrastructure, high adoption rates of diagnostic technologies, and stringent regulatory standards. The region's robust quality control practices and accreditation requirements contribute to the demand for QC materials and solutions in clinical laboratories and healthcare facilities. Additionally, strategic investments in research and development (R&D) and collaborations between industry stakeholders and academic institutions foster innovation and market growth in North America.

Europe represents another major contributor to the Global IVD Quality Control Market, characterized by a well-established healthcare system, strong regulatory oversight, and a high level of healthcare expenditure. The region's emphasis on quality assurance and accreditation standards, such as ISO 15189 and the European Union (EU) Directive on In Vitro Diagnostic Medical Devices (IVDD), drives the adoption of QC materials and solutions in clinical laboratories and diagnostic facilities. Furthermore, strategic initiatives to promote disease surveillance, public health screening, and laboratory proficiency testing contribute to market growth in Europe. Asia-Pacific emerges as a rapidly growing market for IVD quality control, fueled by increasing healthcare expenditure, rising disease burden, and expanding access to healthcare services in countries such as China, India, and Japan. The region's large and diverse population, coupled with rising awareness about preventive healthcare and disease management, drives demand for QC materials and solutions to support diagnostic testing operations in clinical laboratories and healthcare facilities. Moreover, partnerships between international manufacturers and local stakeholders facilitate market penetration and product innovation in Asia-Pacific, further accelerating market growth and diversification.

Latin America and the Middle East & Africa regions exhibit moderate market shares in the Global IVD Quality Control Market. While these regions face challenges related to healthcare access, infrastructure, and economic constraints, efforts to improve disease awareness, diagnostic capabilities, and regulatory frameworks drive market expansion. Collaborative initiatives between public health agencies, non-governmental organizations, and industry stakeholders play a crucial role in advancing QC practices and addressing unmet medical needs in Latin America and the Middle East & Africa.

This report provides an in depth analysis of various factors that impact the dynamics of Global In Vitro Diagnostics (IVD) Quality Control Market. These factors include; Market Drivers, Restraints and Opportunities Analysis.

Drivers, Restraints and Opportunity Analysis

Drivers

• Increasing Emphasis on Laboratory Accreditation
• Development of Multi-Analyte Quality Control Materials
• Expansion of Point-of-Care Testing

• Rising Demand for Quality Assurance in Diagnostics - The rising demand for quality assurance in diagnostics reflects a growing recognition of the critical role that accuracy, reliability, and consistency play in healthcare delivery. Quality assurance processes are essential for ensuring that diagnostic tests and procedures consistently meet predefined standards of performance and reliability, thereby safeguarding patient safety and optimizing clinical decision-making. As healthcare systems worldwide strive to improve the quality and efficiency of diagnostic services, the demand for robust quality assurance measures has become increasingly pronounced.

  Increasing regulatory scrutiny and accreditation requirements have heightened the focus on quality assurance in diagnostics. Regulatory agencies, such as the Food and Drug Administration (FDA) in the United States and the European Medicines Agency (EMA) in Europe, enforce stringent standards for the approval and oversight of diagnostic tests, including requirements related to analytical performance, quality control, and proficiency testing. Compliance with these regulatory requirements is essential for ensuring market access, maintaining public trust, and mitigating legal and financial risks for diagnostic manufacturers and healthcare providers. As such, investment in quality assurance infrastructure and expertise has become a strategic imperative for stakeholders across the diagnostic industry.

  COVID-19 pandemic has underscored the importance of quality assurance in diagnostics, particularly in the context of rapidly deployed testing strategies and pandemic response efforts. As healthcare systems grapple with unprecedented demand for diagnostic testing and face challenges such as supply chain disruptions and workforce shortages, the need for robust quality assurance measures has never been more pressing. From ensuring the accuracy of diagnostic tests for SARS-CoV-2 to maintaining the integrity of laboratory operations amidst heightened demand, quality assurance professionals play a pivotal role in safeguarding the reliability and effectiveness of diagnostic services during public health emergencies.

Restraints

• Regulatory Uncertainties Regarding Quality Control Requirements
• Insufficient Training and Education on Quality Control Practices
• Complexity in Managing Multiple Analytes in Quality Control Materials

• Variability in Performance Across Different Assay Platforms - Variability in performance across different assay platforms is a significant challenge in the field of diagnostics, stemming from differences in technology, methodology, and reagent formulations employed by various manufacturers. These variations can manifest in discrepancies in test results, sensitivity, specificity, and reproducibility, posing risks to patient care and clinical decision-making. As healthcare providers increasingly rely on diagnostic tests for disease diagnosis, monitoring, and treatment guidance, addressing variability in assay performance has become a priority for ensuring the reliability and accuracy of diagnostic results.

  Calibrators, and controls used by assay manufacturers can also contribute to variability in performance. Variations in the quality, purity, and stability of reagents can affect assay sensitivity, specificity, and analytical performance, leading to inconsistencies in test results. Moreover, variations in manufacturing processes, supply chain logistics, and lot-to-lot variability can further exacerbate differences in assay performance across different platforms, posing challenges for standardization and harmonization efforts in the diagnostic industry.

  Performance across different assay platforms requires concerted efforts from stakeholders across the diagnostic ecosystem, including manufacturers, regulatory agencies, and healthcare providers. Standardization of testing protocols, reference materials, and performance criteria can help minimize inter-platform variability and ensure consistency in assay performance. Additionally, proficiency testing programs, external quality assessment schemes, and interlaboratory comparisons play a crucial role in monitoring assay performance, identifying sources of variability, and improving testing accuracy and reliability across different platforms.

Opportunities

• Increasing Adoption of Automation in Quality Control Processes
• Expansion of Quality Control Services and Consulting
• Integration of Artificial Intelligence in Quality Control Analytics

• Opportunities for Innovation in Multi-Analyte Quality Control Materials - Opportunities for innovation in multi-analyte quality control materials represent a promising avenue for advancing quality assurance practices in diagnostics. Multi-analyte quality control materials are designed to simultaneously monitor the performance of multiple analytes across various diagnostic tests and platforms, offering a comprehensive assessment of assay accuracy, precision, and reliability. By incorporating a diverse panel of analytes into a single control material, manufacturers can streamline quality control processes, reduce testing costs, and enhance efficiency in laboratory operations.

  Opportunities for innovation extend to the design of multi-analyte quality control materials with enhanced stability, shelf-life, and traceability features. Advances in packaging materials, lyophilization techniques, and quality control processes enable manufacturers to produce control materials with extended stability under a range of storage conditions, reducing the need for frequent recalibration and minimizing waste. Moreover, the incorporation of barcoding, RFID tagging, and digital tracking technologies enhances traceability and data management capabilities, facilitating compliance with regulatory requirements and accreditation standards, while also enabling real-time monitoring of quality control performance across laboratory networks.

  Opportunities for innovation in multi-analyte quality control materials offer the potential to revolutionize quality assurance practices in diagnostics, enabling laboratories to enhance the reliability, efficiency, and cost-effectiveness of diagnostic testing. By embracing advances in material science, biomarker discovery, and quality control technologies, manufacturers can develop customizable, clinically relevant, and technologically advanced control materials that empower laboratories to deliver high-quality diagnostic services and improve patient care.

Key players in Global In Vitro Diagnostics (IVD) Quality Control Market include :

• Siemens Healthcare GmbH
• Abbott Diagnostics
• Bio-Rad Laboratories
• Danaher Corporation
• Roche Diagnostics
• Thermo Fisher Scientific
• Ortho Clinical Diagnostics
• Sysmex Corporation
• Randox Laboratories

In this report, the profile of each market player provides following information:

• Company Overview and Product Portfolio
• Key Developments
• Financial Overview
• Strategies
• Company SWOT Analysis